DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia

NCT ID: NCT02532686

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.

Detailed Description

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Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.

The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DAAOI-2

DAAOI-2: 500-2000mg/d

Group Type EXPERIMENTAL

DAAOI-2

Intervention Type DRUG

500-2000mg/d, oral, for 6 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral, for 6 weeks

Interventions

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DAAOI-2

500-2000mg/d, oral, for 6 weeks

Intervention Type DRUG

placebo

oral, for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fulfill the DSM-IV criteria of schizophrenia
* Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
* Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
* Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
* Agree to participate in the study and provide informed consent

Exclusion Criteria

* Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
* Meet DSM-IV criteria of mental retardation
* Serious medical or neurological illness
* Pregnancy or lactation
* Inability to follow protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hsien-Yuan Lane

Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry, China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NSC-101-2314-B-039-030-MY3

Identifier Type: -

Identifier Source: org_study_id

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